EP3752091A1 - Process for manufacturing customized facemasks for the treatment of malocclusion - Google Patents
Process for manufacturing customized facemasks for the treatment of malocclusionInfo
- Publication number
- EP3752091A1 EP3752091A1 EP19706451.2A EP19706451A EP3752091A1 EP 3752091 A1 EP3752091 A1 EP 3752091A1 EP 19706451 A EP19706451 A EP 19706451A EP 3752091 A1 EP3752091 A1 EP 3752091A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- forehead
- chin
- facemasks
- patient
- customized
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 238000000034 method Methods 0.000 title claims abstract description 25
- 230000008569 process Effects 0.000 title claims abstract description 24
- 206010061274 Malocclusion Diseases 0.000 title claims abstract description 22
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 21
- 210000001061 forehead Anatomy 0.000 claims abstract description 34
- 238000010146 3D printing Methods 0.000 claims abstract description 8
- 230000001815 facial effect Effects 0.000 claims abstract description 7
- 230000014759 maintenance of location Effects 0.000 claims abstract description 7
- 239000000463 material Substances 0.000 claims abstract description 7
- 229920000299 Nylon 12 Polymers 0.000 claims description 5
- 210000004373 mandible Anatomy 0.000 claims description 4
- 229920000571 Nylon 11 Polymers 0.000 claims description 2
- 239000004952 Polyamide Substances 0.000 claims description 2
- 230000007246 mechanism Effects 0.000 claims description 2
- 229920002647 polyamide Polymers 0.000 claims description 2
- 229920001296 polysiloxane Polymers 0.000 claims description 2
- 230000003340 mental effect Effects 0.000 description 6
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 description 2
- 206010074180 Craniofacial deformity Diseases 0.000 description 2
- 208000008708 Prognathism Diseases 0.000 description 2
- 206010040880 Skin irritation Diseases 0.000 description 2
- 238000013459 approach Methods 0.000 description 2
- 201000005562 gingival recession Diseases 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 210000001847 jaw Anatomy 0.000 description 2
- 210000002050 maxilla Anatomy 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 230000036556 skin irritation Effects 0.000 description 2
- 231100000475 skin irritation Toxicity 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 239000004925 Acrylic resin Substances 0.000 description 1
- 229920000178 Acrylic resin Polymers 0.000 description 1
- 208000004099 Angle Class III Malocclusion Diseases 0.000 description 1
- 206010008723 Chondrodystrophy Diseases 0.000 description 1
- 206010009260 Cleft lip and palate Diseases 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 201000010374 Down Syndrome Diseases 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 206010051821 Retrognathia Diseases 0.000 description 1
- 206010044688 Trisomy 21 Diseases 0.000 description 1
- 206010053613 Type IV hypersensitivity reaction Diseases 0.000 description 1
- 208000008919 achondroplasia Diseases 0.000 description 1
- 230000001270 agonistic effect Effects 0.000 description 1
- 229940072056 alginate Drugs 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 229920000249 biocompatible polymer Polymers 0.000 description 1
- 208000016653 cleft lip/palate Diseases 0.000 description 1
- 230000001010 compromised effect Effects 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 231100000135 cytotoxicity Toxicity 0.000 description 1
- 230000003013 cytotoxicity Effects 0.000 description 1
- 210000002455 dental arch Anatomy 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 239000006260 foam Substances 0.000 description 1
- 231100000025 genetic toxicology Toxicity 0.000 description 1
- 230000001738 genotoxic effect Effects 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 210000004283 incisor Anatomy 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000009653 mandibular growth Effects 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000008450 motivation Effects 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
- 239000011505 plaster Substances 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000007639 printing Methods 0.000 description 1
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- 230000001737 promoting effect Effects 0.000 description 1
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- 230000002441 reversible effect Effects 0.000 description 1
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- 238000007789 sealing Methods 0.000 description 1
- 230000037307 sensitive skin Effects 0.000 description 1
- 201000002859 sleep apnea Diseases 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 239000004753 textile Substances 0.000 description 1
- 230000005951 type IV hypersensitivity Effects 0.000 description 1
- 208000027930 type IV hypersensitivity disease Diseases 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C7/00—Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
- A61C7/06—Extra-oral force transmitting means, i.e. means worn externally of the mouth and placing a member in the mouth under tension
- A61C7/065—Extra-oral force transmitting means, i.e. means worn externally of the mouth and placing a member in the mouth under tension with a chin cup
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C13/00—Dental prostheses; Making same
- A61C13/0003—Making bridge-work, inlays, implants or the like
- A61C13/0006—Production methods
- A61C13/0019—Production methods using three dimensional printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C7/00—Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
- A61C7/002—Orthodontic computer assisted systems
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
-
- A—HUMAN NECESSITIES
- A63—SPORTS; GAMES; AMUSEMENTS
- A63F—CARD, BOARD, OR ROULETTE GAMES; INDOOR GAMES USING SMALL MOVING PLAYING BODIES; VIDEO GAMES; GAMES NOT OTHERWISE PROVIDED FOR
- A63F13/00—Video games, i.e. games using an electronically generated display having two or more dimensions
- A63F13/90—Constructional details or arrangements of video game devices not provided for in groups A63F13/20 or A63F13/25, e.g. housing, wiring, connections or cabinets
- A63F13/98—Accessories, i.e. detachable arrangements optional for the use of the video game device, e.g. grip supports of game controllers
Definitions
- the present invention is related to a process for the manufacturing of facemasks, in particular customized facemasks for maxillary protraction, also known as reverse pull headgears, to be used in the treatment of a malocclusion, namely the Class III malocclusion, in children .
- a malocclusion is a misalignment or incorrect relation between the teeth of the two dental arches when they approach each other as the jaws close.
- malocclusions can be divided mainly into three types according to the classification system defined by Edward Angle, who is considered the father of modern orthodontics.
- Class III malocclusion or mesiocclusion occurs when the mesiobuccal cusp of the maxillary first molar lies posteriorly to the mesiobuccal groove of the mandibular first molar.
- Class III malocclusion has long been considered a complicated maxillofacial disorder, involving a concave profile that results from retrusion of the maxilla, prognathism of the mandible or a combination of the two
- Class III malocclusions have been reported to range between 5% and 15% of the population, depending on the region and the ethnic group [1-3] .
- a skeletal Class III relationship between upper and lower jaw is also typically present in congenital craniofacial deformities, such as cleft lip and palate, Down's syndrome, achondroplasia.
- facemasks currently available consist of a quadrangular metal framework or of a single midline stainless steel rod, to which a forehead pad and a chin pad are connected.
- the 'Petit' facemask featuring the midline rod, is preferred over the type with the framework ( 'Delaire' mask) , as the latter may interfere with sleep, is challenging for children wearing eyeglasses [11], and does not allow mouth opening.
- Facemasks frontal and mental pads are made from hard acrylic resin lined with a soft closed-cell foam on the side contacting the skin. The pads are only available in standardized shapes and in two sizes. In order to apply a forward traction to the maxilla, heavy elastics, transmitting a force as high as 500 grams per side [12], are attached from the intraoral anchorage system, most often provided by a rapid maxillary expansion appliance, to a cross bar extending in front of the mouth ( Figure 1) .
- facemask therapy heavily depends on patient's compliance with the recommended wearing time, possibly ranging between 14 hours and 24 hours a day [13] .
- facemasks can be unaesthetic and uncomfortable [13].
- facemask was rated as the least acceptable device [14] . Beside esthetics, children very often complain about facemask bulkiness and instability, consequently providing so poor cooperation that treatment success can be compromised.
- W02016/012970 A1 discloses a process for manufacturing facemasks which are not particularly customized, but they include one or more sensors for detecting and/or measuring the force exerted by the traction portions.
- the aim of the presented invention is to devise a process for manufacturing customized facemasks for the treatment of Class III malocclusions that can overcome the drawbacks shown in the prior art.
- the process according to the invention is based on the acquisition of 3D digital images of the patient's forehead and chin.
- impressions of the forehead and the chin are obtained using materials that are commonly utilized in dentistry for recording intraoral impressions.
- a 3D scan of the forehead and chin impressions is achieved.
- dentists are not requested to possess any equipments like 3D scanners, multiple image or video cameras and digital reconstruction software, dot or line scans from laser imaging, pattern laser photography, stereo photography, to handle the preparation of customized facemasks. All that is requested from a dentist is to record impressions of only the forehead and chin areas of interest, using a material which is already present in the orthodontics cabinet and whose handling is already mastered by the dentist himself.
- a facial scanning is usually used to scan the whole face surface, to collect data for printing masks covering the whole patient's face and sealing the face area, e.g. for the treatment of sleep apnea, as exemplarily known from US 2018/028,772 Al, and certainly not for forehead and chin only. Then, it should be noted that recording an impression of the entire face would be a either rather unpleasant and experience for a child.
- 3D images obtained from the corresponding impressions can then be used for 3D printing the corresponding forehead and chin pads.
- the customized pads can be adapted to receive suitable temperature and pressure sensors.
- Such sensors can be linked to an application for tablets and smartphones which will include a videogame designed to enhance patients' compliance with wearing the facemask, in line with the new concepts of 'garnification' (see Figure 5, 6A to 6C) . It was indeed demonstrated by previous studies on standard facemasks equipped with temperature sensors inside the frontal pad, as well as on other sensorized removable appliances, that the awareness of being monitored did not result in patients' adherence to the doctor's recommendations for wear time [18, 19] .
- the 'garnification' approach aims to enhance children cooperation by promoting a virtuous competition among the facemask users, which will be linked in a worldwide virtual community.
- Characters, graphics, and strategies of the videogame can be designed to meet preferences and educational needs of the young patients ( Figures 5, 6A to 6C) .
- Figure 1A shows a frontal view of a facemask according to the present invention
- Figure IB shows a side view of the facemask of Figure 1A
- Figure 2 shows a forehead impression of a patient, which can be scanned to obtain a 3D digital image, usable through a 3D printer to print a forehead pad;
- Figure 3 shows a chin impression of a patient, which can be scanned to obtain a 3D digital image, usable through a 3D printer to print a chin pad;
- Figure 4 shows a side view of a patient, wherein the profile line of the face is detected, and a 3D model view of a midline rod obtained from said detection;
- Figure 5 shows a perspective view of a facemask according to the invention, and of a tablet linked to the facemask sensors;
- Figures 6A, 6B and 6C illustrate different screenshot of a smartphone application linked to the facemask sensors .
- the process for manufacturing customized facemasks comprises a step of acquiring 3D images of the patient's forehead and chin, to appropriately model the forehead and chin pads in the facemask.
- the facemask can then be connected to an intraoral appliance by means of elastic bands .
- process for manufacturing customized facemasks 10 comprises the step of assembling said forehead and chin pads 1, 2 into a facemask featuring a facial frame providing a retention to elastic bands meant to be connected to an intraoral appliance.
- the facemask 10 comprises customized forehead and chin pads, mounted onto a customized midline rod.
- the midline rod provides retention to elastic bands.
- the 3D image is acquired by scanning forehead and chin impressions 1' and 2' of the anatomic structures of interest ( Figures 2, 3), recorded with materials commonly used in dentistry for intraoral impressions .
- the corresponding pads can be custom-designed using an appropriate software for 3D digital modelling.
- the 3D digital models of the pads can be produced by a 3D-printer .
- the customized frontal and mental pads are assembled together with a customized midline rod into the facemask 10.
- a patient's side picture is shot to detect the profile line 3' of the patient ( Figure 4), and the midline rod 3 is shaped according to said profile line.
- the midline rod is customized in length, curvature, and position of the retentions for elastic bands by modelling it with a software onto a digital photograph of the patient's face.
- the midline rod features a retentions for the elastic bands at the level of the patient's mouth, providing retention to elastic bands that are to be connected to an intraoral appliance.
- the elastic bands apply a forward traction to the intraoral appliance while transmitting, through the midline rod, a compressive force onto the frontal and mental pads, that act as supports.
- the sliding of the chin pad along the midline rod allows the patient to open and close the lower jaw while wearing the facemask 10.
- chin and forehead pads are expected to result into good fitting, better stability and even pressure distribution over chin and forehead, thus limiting the chance for skin irritation and the risk of gingival recessions.
- pad material can contribute to the overall comfort of the facemask.
- a material suitable for the above purpose is a biocompatible, transparent 3D- printed photopolymer named.
- a good candidate for this polymer is the product MED610, by Stratasys Ltd. The polymer is adequate for prolonged skin contact and has five medical approvals including cytotoxicity, genotoxicity, delayed type hypersensitivity, irritation and United States Pharmacopeia (USP) plastic class VI.
- 3D-printable silicones have been developed for the fabrication of facial prostheses and may be adequate also to produce customized facemasks.
- 3D-printable biocompatible polymers possibly applicable to the production of the customized facemask components are Polyamide 10, Polyamide 11, and Polyamide 12.
- Polyamide 12 is used through a 3D printing process. Polyamide 12 makes the rod lighter and less evident, as compared with the .075" stainless steel used in currently marketed facemasks. Also, the sliding mechanism of the chin cup can be cushioned in order to ease opening and closing movements of the mandible.
- the 'agonistic' drive is expected to represent an additional motivation for the patient, favoring treatment success .
- Angelieri F. Franchi L., Cevidanes L.H.S., Hino C.T., Nguyen T., McNamara J.A. Jr. - Zygomaticomaxillary suture maturation: A predictor of maxillary protraction? Part I - A classification method - Orthod Craniofac Res.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Manufacturing & Machinery (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Dentistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Materials Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)
- Respiratory Apparatuses And Protective Means (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT201800002713A IT201800002713A1 (en) | 2018-02-15 | 2018-02-15 | Manufacturing process of customized face masks for the treatment of malocclusion |
PCT/EP2019/053632 WO2019158627A1 (en) | 2018-02-15 | 2019-02-14 | Process for manufacturing customized facemasks for the treatment of malocclusion |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3752091A1 true EP3752091A1 (en) | 2020-12-23 |
EP3752091B1 EP3752091B1 (en) | 2022-03-09 |
Family
ID=62089974
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19706451.2A Active EP3752091B1 (en) | 2018-02-15 | 2019-02-14 | Process for manufacturing customized facemasks for the treatment of malocclusion |
Country Status (5)
Country | Link |
---|---|
US (1) | US20200397536A1 (en) |
EP (1) | EP3752091B1 (en) |
ES (1) | ES2914385T3 (en) |
IT (1) | IT201800002713A1 (en) |
WO (1) | WO2019158627A1 (en) |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2803560C2 (en) * | 1970-06-17 | 1985-08-29 | geb. Pasgrimaud Louise Anna Nantes Delaire | Orthopedic device for tooth and face adjustment |
US5890891A (en) * | 1998-05-15 | 1999-04-06 | Rmo, Inc. | Reverse pull, extraoral dental assembly with head and body supports and chin stop |
US20060243409A1 (en) * | 2005-04-29 | 2006-11-02 | Fish Jeffrey E | Edge-stiffened sheet material probe |
US7976388B2 (en) * | 2006-03-24 | 2011-07-12 | Umagination Labs, L.P. | Oral care gaming system with electronic game |
US10004866B2 (en) * | 2013-03-15 | 2018-06-26 | Lucy Carol Davis | Facial mask apparatus and method of making |
US9498593B2 (en) * | 2013-06-17 | 2016-11-22 | MetaMason, Inc. | Customized medical devices and apparel |
CA2941626C (en) * | 2014-03-10 | 2018-09-04 | Morpheus Medical Solutions, LLC | Facial mask and method of making |
EP3171814A1 (en) * | 2014-07-25 | 2017-05-31 | Migliorati, Marco | Orthodontic extraoral traction appliance |
US10179035B2 (en) * | 2015-03-04 | 2019-01-15 | Real 3D Polymers Group Llc | Direct 3D-printed orthodontic aligners with torque, rotation, and full control anchors |
KR101667753B1 (en) * | 2015-11-16 | 2016-10-20 | 김은지 | Orthodontic brace |
US20170173371A1 (en) * | 2015-12-21 | 2017-06-22 | Nextteq Llc | Respirator Seals |
WO2017115215A1 (en) * | 2015-12-29 | 2017-07-06 | Koninklijke Philips N.V. | Custom contoured frame for patient interface device |
EP3471599A4 (en) * | 2016-06-17 | 2020-01-08 | Align Technology, Inc. | Intraoral appliances with sensing |
JP7036810B2 (en) * | 2016-06-20 | 2022-03-15 | デンツプライ シロナ インコーポレイテッド | 3D modeling material system and method for manufacturing layered dental products |
-
2018
- 2018-02-15 IT IT201800002713A patent/IT201800002713A1/en unknown
-
2019
- 2019-02-14 ES ES19706451T patent/ES2914385T3/en active Active
- 2019-02-14 US US16/969,761 patent/US20200397536A1/en not_active Abandoned
- 2019-02-14 WO PCT/EP2019/053632 patent/WO2019158627A1/en unknown
- 2019-02-14 EP EP19706451.2A patent/EP3752091B1/en active Active
Also Published As
Publication number | Publication date |
---|---|
ES2914385T3 (en) | 2022-06-10 |
WO2019158627A1 (en) | 2019-08-22 |
US20200397536A1 (en) | 2020-12-24 |
EP3752091B1 (en) | 2022-03-09 |
IT201800002713A1 (en) | 2019-08-15 |
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